Composition comprising extracts of Eucommia ulmoides, Crocus sativus and/or Magnolia officinalis and the use thereof in the treatment of sleep disorders

Abstract

The present invention relates to a composition comprising a mixture comprising or, alternatively, consisting of (a) an extract of Eucommia ulmoides and at least one among (b.1) saffron comprising safranal and (b.2) an extract of Magnolia officinalis and/or Magnolia champaca comprising honokiol, or the mixture thereof, as active components. Furthermore, the present invention relates to an innovative formulation of said composition for the modulated release of said active components. Lastly, the present invention relates to said composition for use in a method for the treatment of sleep cycle dysfunction, in particular both of disorders in the NON-REM stage of sleep and of disorders in the REM stage of deep sleep.

The invention claimed is: 
     
       1. A composition in the form of a three layer tablet comprising:
 (a) a first layer comprising 50 mg to 350 mg dry extract of  Eucommia ulmoides  bark, 
 (b) a second layer comprising a dry extract of  Crocus sativus  stigmas, wherein the second layer comprises 0.1% to 0.5% safranal by weight, and 
 (c) an a third layer comprising a dry extract of: (i)  Magnolia officinalis  bark and/or (ii)  Magnolia champaca  bark, wherein third layer comprises 1.5% to 2.5% honokiol by weight; 
 
       wherein the tablet formulated for oral administration and optionally further comprises at least one food grade or pharmaceutical additive and/or excipient. 
     
     
       2. The composition according to  claim 1 , wherein tablet further comprises magnesium. 
     
     
       3. The composition according to  claim 1 , wherein:
 (i) the dry extract of  Eucommia ulmoides  bark is released into the intestinal tract of a subject 1.5 hours to 8 hours after administration of the composition to said subject; 
 (ii) the dry extract of  Crocus sativus  stigmas is released into the gastric mucosa of the subject in 5 minutes to 45 minutes after the administration of the composition to said subject; 
 (iii) the dry extract of: (i)  Magnolia officinalis  bark and/or (ii)  Magnolia champaca  bark is released in the intestinal tract of the subject in 20 minutes to 120 minutes after the administration of the composition to said subject. 
 
     
     
       4. The composition of  claim 1 , wherein the second layer further comprises magnesium. 
     
     
       5. The composition according to  claim 1 , wherein, in the tablet, the third layer is under the second layer and the first layer is under the third layer. 
     
     
       6. A method of treating a subject for a sleep cycle dysfunction comprising administering an effective amount of the composition according to  claim 1  to the subject. 
     
     
       7. The method of  claim 6 , wherein the subject has insomnia, inability to fall asleep, difficulty in falling asleep, early awakening, interruption of deep sleep by one or more nocturnal awakenings, and excessive daytime sleepiness. 
     
     
       8. The method of  claim 6 , wherein said subject has at least one disorder of the NON-REM stage of sleep and at least one disorder of the REM stage of deep sleep. 
     
     
       9. The method of  claim 6 , wherein the tablet further comprises magnesium. 
     
     
       10. The method of  claim 6 , wherein:
 (i) the dry extract of  Eucommia ulmoides  bark is released into the intestinal tract of a subject 1.5 hours to 8 hours after administration of the composition to said subject; 
 (ii) the dry extract of  Crocus sativus  stigmas is released into the gastric mucosa of the subject in 5 minutes to 45 minutes after the administration of the composition to said subject; 
 (iii) the dry extract of: (i)  Magnolia officinalis  bark and/or (ii)  Magnolia champaca  bark is released in the intestinal tract of the subject in 20 minutes to 120 minutes after the administration of the composition to said subject. 
 
     
     
       11. The method of  claim 6 , wherein the second layer further comprises magnesium. 
     
     
       12. The method of  claim 6 , wherein, in the tablet, the third layer is under the second layer and the first layer is under the third layer.